Optimizing Reperfusion to Improve Outcomes and Neurologic Function

NCT06990867 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: JX10002
• Study Type: interventional
• Target: 740
• Locations: 18 countries
• Sites: 83

Brief Summary

The goal of this study is to evaluate the safety and efficacy of JX10 versus placebo in participants with Acute Ischemic Stroke (AIS) who present for care within 4.5 to 24 hours. The main question the study aims to answer are:

1. 1.JX10 improves functional outcomes as measured by the modified Rankin Scale score when compared with placebo following AIS.
2. 2.Risk of symptomatic intracranial hemorrhage of JX10 in participants with AIS.

Conditions

Acute Ischemic Stroke

Keywords

reperfusion; ORION; Acute Ischemic Stroke; Late Presentation; JX10; thrombolytic

Outcome Measures

Primary Outcomes (2)

• Efficacy: Proportion of participants with no or minimal symptoms (mRS score 0-1) at 90 days

  90 days

• Safety: Incidence of symptomatic intracranial hemorrhage within 36 hours post-randomization

  Within 36 hours post-randomization

Secondary Outcomes (4)

• Ordinal mRS score (0-6), based on a 6-point ordinal scale at 90 days

  90 days

• Proportion of participants with functional independence at 90 days

  90 days

• Incidence of adverse events (AEs) and serious adverse events (SAEs)

  90 days

• Incidence of major bleeding within 24 hours and 14 days of study treatment

  Within 24 hours and 14 days of study treatment

Study Arms (5)

Part 1 - JX10 (1mg/kg)

EXPERIMENTAL

Drug: JX10

Part 1 - JX10 (3mg/kg)

EXPERIMENTAL

Drug: JX10

Part 1 - Placebo

PLACEBO COMPARATOR

Drug: Placebo

JX10 Part 2 - (1 or 3 mg/kg)

EXPERIMENTAL

Drug: JX10

Part 2 - Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

JX10 DRUG

JX10 is a thrombolytic agent.

JX10 Part 2 - (1 or 3 mg/kg); Part 1 - JX10 (1mg/kg); Part 1 - JX10 (3mg/kg)

Placebo DRUG

Placebo is being used as the comparator.

Part 1 - Placebo; Part 2 - Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and ≤ 90 years old.
• Acute ischemic stroke with compatible clinical presentation and symptomatic high grade or complete occlusion of the intracranial internal carotid, M1, M2 or distal branches of the middle cerebral artery (MCA), anterior cerebral artery (ACA), or posterior cerebral artery (PCA).
• Radiographic evidence of salvageable tissue.
• Pre-treatment score of NIHSS ≥ 5.

You may not qualify if:

• Radiographic findings pre-randomization of any of the following:
• Large core infarction, or
• Occlusion in more than 1 vascular territory, or
• Significant mass effect or clinically significant cerebral edema, or
• Evidence of acute intracranial or extracranial hemorrhage, intracranial tumor (except small meningioma), neoplasm, or arteriovenous malformation), or
• Clinical history, past imaging, or clinical judgement suggests that the intracranial occlusion is chronic.
• Medical history or active clinically significant bleeding, lesions, or conditions (at the investigator's judgement) considered to be of significant risk for major bleeding.
• Severe, uncontrolled hypertension (systolic blood pressure ≥ 185 mmHg or diastolic blood pressure ≥ 110 mmHg) that cannot be controlled with antihypertensive therapy.
• Known bleeding diathesis (hereditary or acquired) or any significant coagulopathy. Specifically, platelet count \< 100,000/μL, international normalized ratio \> 1.7, aPTT \> 40 seconds, or prothrombin time \> 15 seconds.
• Major trauma, surgery, or invasive procedures.
• Pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluations of this study.

Sponsors & Collaborators

• Corxel Pharmaceuticals: lead

Study Sites (83)

Corxel Investigational Site

Long Beach, California, 90806, United States

RECRUITING

Corxel Investigational Site

Sacramento, California, 95817, United States

RECRUITING

Corxel Investigational Site

Colorado Springs, Colorado, 80909, United States

RECRUITING

Corxel Investigational Site

Washington D.C., District of Columbia, 20007, United States

RECRUITING

Corxel Investigational Site

Delray Beach, Florida, 33484, United States

RECRUITING

Corxel Investigational Site

Chicago, Illinois, 60616, United States

RECRUITING

Corxel Investigational Site

Wichita, Kansas, 67214, United States

RECRUITING

Corxel Investigational Site

Baltimore, Maryland, 21215, United States

RECRUITING

Corxel Investigational Site

Kalamazoo, Michigan, 49048, United States

RECRUITING

Corxel Investigational Site

Traverse City, Michigan, 49684, United States

RECRUITING

Corxel Investigational Site

St Louis, Missouri, 63110, United States

RECRUITING

Corxel Investigational Site

Great Neck, New York, 11021, United States

RECRUITING

Corxel Investigational Site

New York, New York, 10029, United States

RECRUITING

Corxel Investigational Site

Toledo, Ohio, 43606, United States

RECRUITING

Corxel Investigational Site

Tulsa, Oklahoma, 74104, United States

RECRUITING

Corxel Investigational Site

Dallas, Texas, 75246, United States

RECRUITING

Corxel Investigational Site

Houston, Texas, 77030, United States

RECRUITING

Corxel Investigational Site

Ghent, 9000, Belgium

RECRUITING

Corxel Investigational Site

Blagoevgrad, Bulgaria

RECRUITING

Corxel Investigational Site

Burgas, Bulgaria

RECRUITING

Corxel Investigational Site

Pleven, Bulgaria

RECRUITING

Corxel Investigational Site

Plovdiv, Bulgaria

RECRUITING

Corxel Investigational Site

Sofia, 1606, Bulgaria

RECRUITING

Corxel Investigational Site

Edmonton, Canada

RECRUITING

Corxel Investigational Site

Kingston, Canada

RECRUITING

Corxel Investigational Site

Baotou, China

RECRUITING

Corxel Investigational Site

Beijing, China

RECRUITING

Corxel Investigational Site

Beijing, China

RECRUITING

Corxel Investigational Site

Changchun, China

RECRUITING

Corxel Investigational Site

Guangzhou, China

RECRUITING

Corxel Investigational Site,

Harbin, China

RECRUITING

Corxel Investigational Site

Harbin, China

RECRUITING

Corxel Investigational Site

Kaili, China

RECRUITING

Corxel Investigational Site

Linfen, China

RECRUITING

Corxel Investigational Site

Shanghai, China

RECRUITING

Corxel Investigational Site

Shenyang, China

RECRUITING

Corxel Investigational Site

Suzhou, China

RECRUITING

Corxel Investigational Site

Weifang, China

RECRUITING

Corxel Investigational Site

Xuzhou, China

RECRUITING

Corxel Investigational site

Lille, France

RECRUITING

Corxel Investigational site

Paris, France

RECRUITING

Corxel Investigational Site

Altenburg, Germany

RECRUITING

Corxel Investigational Site

Leipzig, Germany

RECRUITING

Corxel Investigational Site

Lübeck, Germany

RECRUITING

Corxel Investigational Site

Trier, Germany

RECRUITING

Corxel Investigational Site

Athens, Greece

RECRUITING

Corxel Investigational Site

Chaïdári, Greece

RECRUITING

Corxel Investigational Site

Pátrai, Greece

RECRUITING

Corxel Investigational Site

Thessaloniki, Greece

RECRUITING

Corxel Investigational Site

Pavia, Italy

RECRUITING

Corxel Investigational Site

Roma, Italy

RECRUITING

Corxel Investigational Site

Fukuoka, Japan

RECRUITING

Corxel Investigational Site

Hyōgo, Japan

RECRUITING

Corxel Investigational site

Ibaraki, Japan

RECRUITING

Corxel Investigational Site

Kamakura, Japan

RECRUITING

Corxel Investigational Site

Meguro City, Japan

RECRUITING

Corxel Investigational Site

Mitaka, Japan

RECRUITING

Corxel Investigational Site

Miyagi, Japan

RECRUITING

Corxel Investigational site

Toyota, Japan

RECRUITING

Corxel Investigational Site

Yamagata, Japan

RECRUITING

Corxel Investigational Site

Yamaguchi, Japan

RECRUITING

Corxel Investigational Site

Daugavpils, Latvia

RECRUITING

Corxel Investigational Site

Riga, Latvia

RECRUITING

Corxel Investigational Site

Kaunas, Lithuania

RECRUITING

Corxel Investigational Site

Vilnius, Lithuania

RECRUITING

Corxel Investigational Site

Kuching, Malaysia

RECRUITING

Corxel Investigational Site

Braga, Portugal

RECRUITING

Corxel Investigational Site

Loures, Portugal

RECRUITING

Corxel Investigational Site

Belgrade, Serbia

RECRUITING

Corxel Investigational Site

Kragujevac, Serbia

RECRUITING

Corxel Investigational Site

Niš, Serbia

RECRUITING

Corxel Investigational Site

Novi Sad, Serbia

RECRUITING

Corxel Investigational Site

Seoul, South Korea

RECRUITING

Corxel Investigational Site

A Coruña, Spain

RECRUITING

Corxel Investigational Site

Albacete, Spain

RECRUITING

Corxel Investigational Site

Barcelona, Spain

RECRUITING

Corxel Investigational Site

Girona, Spain

RECRUITING

Corxel Investigational Site

Madrid, Spain

RECRUITING

Corxel Investigational Site

Málaga, Spain

RECRUITING

Corxel Investigational Site

Seville, Spain

RECRUITING

Corxel Investigational Site

Valencia, Spain

RECRUITING

Corxel Investigational Site

Bangkok, Thailand

RECRUITING

Corxel Investigational Site

Khon Kaen, Thailand

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Senior Director, Clinical Operations

  Corxel Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Corxel Pharmaceuticals Study Information Center

CONTACT

201-268-3723; Information.center@corxelbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: May 25, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): October 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 13, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4); SE (4); BU (5); PT (2); CN (14); BE (1); TH (2); JP (10); MY (1); US (17); IT (2); LI (2); KR (1); CA (2); FR (2); GR (4); ES (8); LA (2)